Ingredient safety check
Type a bulk substance, drug, or excipient. Matches are by name across salt forms; confirm the exact substance and salt against the source.
The lists
503A Category 2: significant safety risks (6)
- Cesium Chloride
- Domperidone
- Germanium Sesquioxide
- Ibutamoren Mesylate
- Kisspeptin-10
- Quinacrine Hydrochloride for intrauterine administration
21 CFR 216.24: withdrawn or removed for safety or effectiveness (85)
| Substance | Products that may not be compounded |
|---|---|
| Adenosine phosphate | All drug products containing adenosine phosphate. |
| Adrenal cortex | All drug products containing adrenal cortex. |
| Alatrofloxacin mesylate | All drug products containing alatrofloxacin mesylate. |
| Aminopyrine | All drug products containing aminopyrine. |
| Astemizole | All drug products containing astemizole. |
| Azaribine | All drug products containing azaribine. |
| Benoxaprofen | All drug products containing benoxaprofen. |
| Bithionol | All drug products containing bithionol. |
| Bromfenac sodium | All drug products containing bromfenac sodium (except ophthalmic solutions). |
| Bromocriptine mesylate | All drug products containing bromocriptine mesylate for prevention of physiological lactation. |
| Butamben | All parenteral drug products containing butamben. |
| Camphorated oil | All drug products containing camphorated oil. |
| Carbetapentane citrate | All oral gel drug products containing carbetapentane citrate. |
| Casein, iodinated | All drug products containing iodinated casein. |
| Cerivastatin sodium | All drug products containing cerivastatin sodium. |
| Chloramphenicol | All oral drug products containing chloramphenicol. |
| Chlorhexidine gluconate | All tinctures of chlorhexidine gluconate formulated for use as a patient preoperative skin preparation. |
| Chlormadinone acetate | All drug products containing chlormadinone acetate. |
| Chloroform | All drug products containing chloroform. |
| Cisapride | All drug products containing cisapride. |
| Cobalt | All drug products containing cobalt salts (except radioactive forms of cobalt and its salts and cobalamin and its derivatives). |
| Dexfenfluramine hydrochloride | All drug products containing dexfenfluramine hydrochloride. |
| Diamthazole dihydrochloride | All drug products containing diamthazole dihydrochloride. |
| Dibromsalan | All drug products containing dibromsalan. |
| Diethylstilbestrol | All oral and parenteral drug products containing 25 milligrams or more of diethylstilbestrol per unit dose. |
| Dihydrostreptomycin sulfate | All drug products containing dihydrostreptomycin sulfate. |
| Dipyrone | All drug products containing dipyrone. |
| Encainide hydrochloride | All drug products containing encainide hydrochloride. |
| Esmolol hydrochloride | All parenteral dosage form drug products containing esmolol hydrochloride that supply 250 milligrams/milliliter of concentrated esmolol per 10-milliliter ampule. |
| Etretinate | All drug products containing etretinate. |
| Fenfluramine hydrochloride | All drug products containing fenfluramine hydrochloride. |
| Flosequinan | All drug products containing flosequinan. |
| Gatifloxacin | All drug products containing gatifloxacin (except ophthalmic solutions). |
| Gelatin | All intravenous drug products containing gelatin. |
| Glycerol, iodinated | All drug products containing iodinated glycerol. |
| Gonadotropin, chorionic | All drug products containing chorionic gonadotropins of animal origin. |
| Grepafloxacin | All drug products containing grepafloxacin. |
| Mepazine | All drug products containing mepazine hydrochloride or mepazine acetate. |
| Metabromsalan | All drug products containing metabromsalan. |
| Methamphetamine hydrochloride | All parenteral drug products containing methamphetamine hydrochloride. |
| Methapyrilene | All drug products containing methapyrilene. |
| Methopholine | All drug products containing methopholine. |
| Methoxyflurane | All drug products containing methoxyflurane. |
| Mibefradil dihydrochloride | All drug products containing mibefradil dihydrochloride. |
| Nitrofurazone | All drug products containing nitrofurazone (except topical drug products formulated for dermatologic application). |
| Nomifensine maleate | All drug products containing nomifensine maleate. |
| Novobiocin sodium | All drug products containing novobiocin sodium. |
| Ondansetron hydrochloride | All intravenous drug products containing greater than a 16 milligram single dose of ondansetron hydrochloride. |
| Oxyphenisatin | All drug products containing oxyphenisatin. |
| Oxyphenisatin acetate | All drug products containing oxyphenisatin acetate. |
| Pemoline | All drug products containing pemoline. |
| Pergolide mesylate | All drug products containing pergolide mesylate. |
| Phenacetin | All drug products containing phenacetin. |
| Phenformin hydrochloride | All drug products containing phenformin hydrochloride. |
| Phenylpropanolamine | All drug products containing phenylpropanolamine. |
| Pipamazine | All drug products containing pipamazine. |
| Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride, and bisacodyl | All drug products containing polyethylene glycol 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution, and 10 milligrams or more of bisacodyl delayed-release tablets. |
| Potassium arsenite | All drug products containing potassium arsenite. |
| Potassium chloride | All solid oral dosage form drug products containing potassium chloride that supply 100 milligrams or more of potassium per dosage unit (except for controlled-release dosage forms and those products formulated for preparation of solution prior to ingestion). |
| Povidone | All intravenous drug products containing povidone. |
| Propoxyphene | All drug products containing propoxyphene. |
| Rapacuronium bromide | All drug products containing rapacuronium bromide. |
| Reserpine | All oral dosage form drug products containing more than 1 milligram of reserpine. |
| Rofecoxib | All drug products containing rofecoxib. |
| Sibutramine hydrochloride | All drug products containing sibutramine hydrochloride. |
| Sparteine sulfate | All drug products containing sparteine sulfate. |
| Sulfadimethoxine | All drug products containing sulfadimethoxine. |
| Sulfathiazole | All drug products containing sulfathiazole (except for those formulated for vaginal use). |
| Suprofen | All drug products containing suprofen (except ophthalmic solutions). |
| Sweet spirits of nitre | All drug products containing sweet spirits of nitre. |
| Tegaserod maleate | All drug products containing tegaserod maleate. |
| Temafloxacin hydrochloride | All drug products containing temafloxacin hydrochloride. |
| Terfenadine | All drug products containing terfenadine. |
| 3,3′,4′,5-tetrachlorosalicylanilide | All drug products containing 3,3′,4′,5-tetrachlorosalicylanilide. |
| Tetracycline | All liquid oral drug products formulated for pediatric use containing tetracycline in a concentration greater than 25 milligrams/milliliter. |
| Ticrynafen | All drug products containing ticrynafen. |
| Tribromsalan | All drug products containing tribromsalan. |
| Trichloroethane | All aerosol drug products intended for inhalation containing trichloroethane. |
| Troglitazone | All drug products containing troglitazone. |
| Trovafloxacin mesylate | All drug products containing trovafloxacin mesylate. |
| Urethane | All drug products containing urethane. |
| Valdecoxib | All drug products containing valdecoxib. |
| Vinyl chloride | All aerosol drug products containing vinyl chloride. |
| Zirconium | All aerosol drug products containing zirconium. |
| Zomepirac sodium | All drug products containing zomepirac sodium. |
21 CFR 216.24 (81 FR 69676, Oct. 7, 2016, as amended at 83 FR 63573, Dec. 11, 2018); eCFR as of 2026-11-04.
21 CFR 216.23: the 503A bulks list (6 placed, 4 not placed)
Can be used under section 503A
- Brilliant Blue G, also known as Coomassie Brilliant Blue G-250
- Cantharidin (for topical use only)
- Diphenylcyclopropenone (for topical use only)
- N-acetyl-D-glucosamine (for topical use only)
- Squaric acid dibutyl ester (for topical use only)
- Thymol iodide (for topical use only)
FDA decided not to place on the list
- Oxitriptan
- Piracetam
- Silver Protein Mild
- Tranilast
21 CFR 216.23 (84 FR 4710, Feb. 19, 2019).
503A Category 1: under evaluation (49)
- 7 Keto Dehydroepiandrosterone
- Acetyl L Carnitine/Acetyl-L- carnitine Hydrochloride
- Alanyl-L-Glutamine
- Aloe Vera/ Aloe Vera 200:1 Freeze Dried
- Alpha Lipoic Acid
- Ammonium Tetrathiomolybdate
- Artemisia/Artemisinin
- Astragalus Extract 10:1
- Boswellia
- Choline Chloride
- Chondroitin Sulfate
- Chrysin
- Coenzyme Q10
- Creatine Monohydrate
- Curcumin
- Deoxy-D-Glucose
- Dichloroacetate
- Diindolylmethane
- Dimercapto-1- propanesulfonic acid (DMPS)
- EGCg
- Enclomiphene Citrate
- Ferric Subsulfate
- GHK-Cu (except for injectable routes of administration)
- Glutaraldehyde
- Glutathione
- Glycolic Acid
- Glycyrrhizin
- Kojic Acid
- L-Citrulline
- L-Theanine
- Melatonin
- Methylcobalamin
- Methylsulfonylmethane (MSM)
- Nettle leaf (Urtica dioica subsp. dioica leaf)
- Nicotinamide Adenine Dinucleotide (NAD)
- Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)
- Pregnenolone
- Pyridoxal 5-Phosphate Monohydrate
- Pyruvic Acid
- Quercetin/Quercetin Dihydrate
- Quinacrine Hydrochloride (except for intrauterine administration)
- Resveratrol
- Ribose (D)
- Rubidium Chloride
- Tea tree oil (Melaleuca alternifolia leaf oil)
- Trichloroacetic Acid
- Ubiquinol 30% Powder
- Vanadium
- Vasoactive Intestinal Peptide
503A Category 3: nominated without adequate support (311)
- Acetanilide
- Adenosine-5-triphosphate disodium salt
- Alcloxa
- Aldioxa
- Aldosterone
- Alfalfa
- Alfalfa leaves
- Almadrate sulfate
- Aloin
- Alpha Ketoglutaric acid
- Alumina Powder, hydrated
- Aluminum phosphate
- Aluminum phosphate, Adjuvant
- Aminacrine Hydrochloride
- Ammonium bromide
- Ammonium hydroxide
- Anise seed
- Argentyn
- Aromatic powder
- Asafetida
- Asafetida tincture
- Asclepias tuberosa
- Asparagus
- Attapulgite
- Barosma
- Bean
- Beechwood creosote
- Betamechlomathasone
- Beta-Nicotinamide Adenine Dinucleotide Disodium Salt Trihydrate
- Bichloroacetic acid/ Dichloroacetic acid
- Calcium Folinate
- Calcium Glycinate
- Capsaicin palmitate
- Carbazochrome
- Carbimazole
- Carbolic Acid
- Carbomer Gel - Aqueous
- Carbomer Gel - Hydroalcoholic
- Cedarwood Essential Oil
- Chlorhexidine Diacetate Hydrate
- Choline bitartrate
- Choline magnesium trisalicylate
- Chromium glycinate
- Cibinetide (ARA-290)
- Coenzyme Q50
- Copper
- Magnesium ascorbate
- Copper Bisglycinate
- Copper Hydrosol
- DL-Phenylalanine
- Decylmethylsulfoxide
- Diaminopyridine (3,4-)
- Dimethyl Ketone
- Dimethylaminoethanol Bitartrate
- Dimethylglycine Hydrochloride
- Dinitrochlorobenzene
- Edetate tetrasodium tetrahydrate
- Ethanolamine
- Folinic Acid Calcium Salt
- Fructose and Pregelatinized Starch
- Gamma Aminobutyric Acid
- GHRP-2
- GHRP-6
- Ginger root powder
- Ginkgo Biloba Standardized Extract
- Gluconic acid calcium salt
- Glycerol Formal
- Glydiazinamide
- Grape seed oil
- Gum Arabic
- Heart-leaf nettle leaf (Urtica chamaedryoides leaf)
- Hyaluronic Acid Sodium Salt
- Hydrazine sulfate
- Iodochlorhydroxyquin
- Indigo Carmine
- Indole-3-carbinol
- Inositol Hexanicotinate
- Iron Glycinate Chelate
- Karaya Gum
- L-Carnosine
- L-Ornithine Hydrochloride
- Levulose
- L-Histidine Monohydrochloride, Monohydrate
- Lactose, Monohydrate and Corn Starch
- Lactose, Monohydrate and Microcrystalline Cellulose
- Lactose, Monohydrate and Powdered Cellulose
- Lactose, spray dried
- L-Aspartic Acid Sodium Salt
- Levomenthol
- Liquid Paraffin
- Lysine aspirin
- Natural estrogenic hormone
- Magnesium bisglycinate
- Magnesium bisglycinate dehydrate
- Magnesium glycinate
- Magnesium glycinate 15%
- Malt
- Malt soup extract
- Maltodextrin
- Manganese Bisglycinate
- Manganese citrate
- m-cresol
- Mechano growth factor (MGF)
- Menfegol
- Menthol/peppermint oil
- Meralein sodium
- Merbromin
- Mercufenol chloride
- Mercuric chloride
- Mercuric oxide
- Mercuric salicylate
- Mercuric sulfide, red/Mercury sulfide
- Mercury
- Mercury-containing ingredient
- Mercury oleate
- Methapyrilene fumarate
- Methapyrilene Hydrochloride
- Methoxyphenamine Hydrochloride
- Methoxypolyoxyethyleneglycol 350 laurate
- Methyl nicotinate
- Milk and molasses
- Milk of sulfur
- milk solids, dried
- Mineral Oil and Lanolin Alcohols
- Molasses
- Myrrh gum tincture
- Monosodium L-Aspartate
- Mullein
- Molybdenum Glycinate
- Mycozyme
- Myrrh tincture
- Mustard oil (alltlishthiocyanate)
- Phenyltoloxamine dihydrogen citrate
- Phenyltoloxamine Hydrochloride
- Phosphate fluoride
- Phosphorated carbohydrate
- Phosphorus
- Phytolacca
- Picrotoxin
- Pimobendan
- Pine tar
- Piperocaine Hydrochloride
- Nickel-pectin
- Non-Fat Dry Milk
- Nonylphenoxypoly (ethyleneoxy) ethanol iodine
- Nonylphenoxypoly nonoxynol 9
- Noscapine Hydrochloride
- Nutmeg oil
- Nux vomica extract
- Obtundia
- Octyl triazone
- Oil of erigeron
- Organic vegetables
- Orthophosphoric acid
- Ox bile
- Ox bile extract
- Oxyquinoline
- Padimate a
- Pambron
- Pantothenic acid
- Papaya enzymes
- Papaya, natural
- P-T-butyl-m-cresol
- Para-chloromercuriphenol
- Parethoxycaine Hydrochloride
- Parsley
- Passion flower extract
- Pennyroyal Oil
- Pentylenetetrazole
- Peppermint Oil and Sage Oil
- Peruvian balsam (Myroxylon balsamum var. pereirae balsam)
- Peruvian balsam oil
- Petrolatum and Lanolin Alcohols
- Phenacaine Hydrochloride
- Phenindamine Tartrate
- Phenolate sodium
- Phenolphthalein
- Phenoxyacetic acid
- Phenyl salicyiate (Salol)
- Phenyl salicylate
- Shark liver oil
- Shark liver oil (combination only)
- Skin protectant
- Senecio aureus
- Senna syrup
- Serotonin Hydrochloride
- Sesame Seed
- Short Chain Fatty Acid
- Silver (see also argentyn)
- Silver, colloidal
- Sodium
- Pipsissewa
- Piracetam dihydrogen citrate
- Piscidia erythrina
- Plantago ovata husks
- Poloxamer-iodine complex
- Polydimethylsiloxane and poloxamer
- Polyols, liquid
- Polyoxeythylene laurate
- Potash Lye
- Potassium chlorate
- Potassium ferrocyanide
- Potassium salicylate
- Povidone-vinylacetate copolymers
- Prolase
- Protease
- Prune concentrate dehydrate
- Prune powder
- Psyllium hydrophillic mucilloid
- Pyruvic aldehyde
- Pyruvic Aldehyde 40% Aqueous Solution
- Racephedrine hydrochloride
- Red petrolatum
- Reosote
- Rhubarb fluid extract
- Rhubarb, Chinese
- Rice pollishings
- Romohydrate
- Sabadilla, alkaloids
- Sage oil
- Salicyl alcohol
- Sanguinaria extract
- Saw palmetto
- Scopolamine aminoxide Hydrobromide
- Sea mineral
- Secretin, human 99%
- Selenium
- Theophylline calcium salicylate
- Thiocyanoacetate
- Thonzylamine Hydrochloride
- Thylene blue
- Thymulin acetate
- Tolindate
- Toltrazuril
- Tolu preparations
- Tricalcium phosphate
- Triethanolamine
- Trillium
- Triple dye
- Triticum
- Turpentine Oil
- Sodium 3, 4-dimethylphenyl-glyoxylate
- Sodium acetylsalicylate
- Sodium aluminum chlorohydroxy lactate
- Sodium aspartate
- Sodium biphosphate
- Sodium bisulfate
- Sodium borate monohydrate
- Sodium caseinate
- Sodium diacetate
- Sodium dichromate
- Sodium dihydrogen phosphate monohydrate
- Sodium Hydroxide 1N
- Sodium nitrate
- Sodium octanoate
- Sodium oleate
- Sodium para-amino benzoate
- Sodium perborate
- Sodium perborate monohydrate
- Sodium phosphate
- Sodium salicylic acid phenolate
- Sodium potassium tartrate
- Soft Paraffin
- Sols, secondary
- Soy meal
- Soybean protein
- Stannous pyrophosphate and zinc citrate
- Stevia Powder Extract
- Strychnine
- Sucros
- Sugars
- Sulferated oils of turpentine
- Squill preparations
- Sulfobutylether B-Cyclodextrin
- Tannic acid glycerite
- Taraxacum officinale
- Tartrate (acid or salt)
- Tetrahydrochloride
- Thenyldiamine Hydrochloride
- Theobromine Sodium Salicylate
- Turpentine Oil (oral)
- Turpentine Oil (rectified)
- Turpentine Oil (spirits of turpentine)
- Turpentine Oil (spirits of turpentine, oral)
- Turpentine Oil (spirits of turpentine, topical)
- Turpentine, Venice
- Uinolinium bromide
- Ulose
- Uva ursi, extract of
- Uva ursi, potassium extract
- Valic acid
- Vegetable (green)
- Verapamil
- Vitamin A acetate
- Vitromersol
- Wax, Anionic Emulsifying
- Wheat germ
- Wheat germ (triticum aestivum/vulgare extract)
- White ointment
- Woodruff
- Yeast
- Yellow mercuric oxide
- Zinc
- Zinc caprylate
- Zinc citrate
- Zinc phenol sulfonate
- Zinc picolinate
- Zinc propionate
- Zinc sulfide
- Zirconium oxide
- Zyloxin
Categories from FDA's 503A bulk drug substance categories (updated 2026-05-14); see FDA's 503A bulk substances page for the interim policy.
Demonstrably difficult to compound: proposed, not in effect
FDA has proposed these categories (Proposed rule, 89 FR 19776 (March 20, 2024), docket FDA-2023-N-0061; proposed 21 CFR 216.25). No demonstrably-difficult-to-compound list is in effect yet.
- Oral solid modified-release drug products that employ coated systems
- Liposome drug products
- Drug products produced using hot melt extrusion
Hazardous drugs: NIOSH List of Hazardous Drugs in Healthcare Settings, December 2024 (239 drugs), with handling under USP <800>. Shortages: FDA drug shortage data through openFDA, checked live.
For licensed clinicians. Use with clinical judgment.